(Matt Briney, Unsplash)
24 January 2018. Two federal agencies sent warning letters to companies the agencies say are illegally marketing products making false or unsubstantiated claims about their treating opioid addiction or withdrawal. The letters were sent by the U.S. Food and Drug Administration and Federal Trade Commission to vendors of 12 products, with orders to take action within 3 weeks.
The well-documented opioid crisis in the U.S. and elsewhere shows little sign of abating, with much of the problem linked to abuse of opioid pain drugs. A report by the National Academies of Sciences, Engineering, and Medicine in July 2017 spells out the scope of the crisis, with some 2 million Americans age 12 and older addicted to prescription opioid drugs and another 600,000 addicted to heroin. The most visible and immediate effect of the emergency is the growing number of overdoses and deaths that result. National Institute on Drug Abuse, part of National Institutes of Health, cites data showing more than 90 Americans each day die from opioid overdose.
FDA and FTC say the cited companies make claims unsubstantiated by evidence, such as “a life without the irritability, cravings, restlessness, excitability, exhaustion and discomfort associated with the nightmare of addiction and withdrawal symptoms,” and “safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.” The agencies say products with unsubstantiated claims may prevent those addicted to opioids from seeking approved treatments that have been demonstrated to be safe and effective, delay their path to recovery, and put them at greater risk of death.
- GUNA Inc. product: GUNA-ADDICT 1
- King Bio Inc. product: AddictaPlex
- Opiate Freedom Center. product: Opiate Freedom 5-Pack
- U4Life LLC. product: Mitadone Anti-Opiate Aid Plus Extra Strength
- Ryan Donnelly. product: CalmSupport
- Richie Ogulnick. products: TaperAid and TaperAid Complete
- Medicus Holistic Alternatives LLC. product: Natracet
- Nutracore Health Products LLC. product: Opiate DeTox Pro
- Healthy Healing LLC. product: Withdrawal Support, formerly called Addiction Withdrawal
- Soothedrawal Inc. product: Soothedrawal Daytime and Nighttime Formulas
- Choice Detox Center Inc. product: Nofeel
FDA and FTC also sent warning letters to 4 unnamed marketers of opioid cessation products. The agencies say all of the companies use online platforms to make illegal claims about their products’ ability to cure, treat, or prevent a disease. Selling unapproved products claiming to treat opioid addiction and withdrawal is a violation of the Federal Food, Drug, and Cosmetic Act administered by FDA. Making false or unsubstantiated claims about therapies violates the Federal Trade Commission Act, which prohibits deceptive advertising.
The warning letters call for the companies to respond in 15 working days with the actions taken to address the agencies’ concerns. Failure to correct the violations, say the agencies, can result in law enforcement actions, such as seizure or injunction.
Also today, the FTC and Substance Abuse and Mental Health Services Administration, in the Department of Health and Human Services, issued a fact sheet to help clarify real treatments for opioid addiction and scams. The page includes resources to contact for help in finding legitimate treatments.
More from Science & Enterprise:
- Highly Targeted Opioid Designed to Avoid Side Effects
- Two Opioid Addiction Treatments Found Safe, Effective
- Start-Up Formed to Develop Non-Opioid Pain Drugs
- Here’s What a Real Opioid Emergency Looks Like
- Many Surgical Opioid Drugs Go Unused, Not Disposed
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